Addendum
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Operator’s Manual Addendum
Vigileo Monitor Cardiac Output/Oximetry Monitor Update to Chapter 1, Section 1.1 – Indications for Use The Vigileo monitor allows the clinician to continuously measure hemodynamic parameters such as cardiac output and oximetry to assess oxygen delivery and consumption. When connected to an Edwards oximetry catheter the monitor measures oximetry in adults and pediatrics.
Update to Chapter 2, Table 2-4, Monitor Back Symbols and Connectors Change Figure Number 20 to add a symbol for Refurbished Unit. Figure Number 20
Symbol
Description
P/N
Part Number
REF
Model Designation Refurbished Unit (if applicable)
Update to: Chapter 4, Section 4.4.1 - Table 4-2 Environmental Specifications Appendix A, Table A-2 - Environmental Specifications The Operating temperature without Optical Module has been corrected to 0 to 45°C. Parameter Operating temperature without Optical Module Operating temperature with Optical Module Storage Temperature Relative Humidity, Operating and Storage Operating Atmospheric Pressure
Value 0 to 45 °C 10 to 37 °C -25 to 70 °C 10% to 95%, non-condensing 696 to 1013 hPa
Update to Chapter 4, Section 4.9.1, Starting the Monitor A description for the Power-On Clear Patient Data Screen as follows: Upon successful completion of the Power-On Self Tests, if any patient data exists that is less than 8 hours old, the Vigileo monitor asks if that patient’s data should be cleared (see Figure 4-2). If all patient data is more than eight hours old, the data is automatically deleted and the monitor displays the Power-On Patient Information Screen (See Figure 4-3). Edwards Lifesciences 1
Figure 4-2 Power-On Clear Patient Data Screen
Figure 4-3 Power-On Patient Information Screen
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Table 4-3 lists the Vigileo monitor actions as a result of choosing No or Yes to the question: Clear patient data profiles? as shown in the above screen. Table 4-3 Vigileo Monitor Clear Patient Data Processing If NO is selected, Vigileo monitor:
If YES is selected, Vigileo monitor:
• Activates previous record for continuation • Keeps alarm settings and enable/disable alarms status • Displays the default Home screen
• Clears patient data from memory • Resets alarm limits to defaults • Enables all alarms • Starts a new patient record • Sets the label in the Oximetry Frame to “ScvO2” • Displays the Patient Information Screen
While in operation, the monitor will store up to 72 hours of trend data. If monitoring continues beyond 72 hours, the most recent data will be added to the trend, and the oldest data removed. When power is lost, the monitor retains all 72 hours of information. If power is immediately restored, all information will be retained and displayed. As time passes without power, however, an equal amount of data is lost (for example, after 4 hours, the oldest 4 hours of retained data is lost). The monitor will also store any specific selections made regarding graph selections as well as user-entered patient data. Update to Chapter 6, Section 6.3.4, Table 6-2 “CO Trend Setup Options” Clarification to the Averaging Time Description: Averaging Time
Sets the amount of time that CO/CI, SVR/SVRI, SV/SVI, and SVV are averaged. Select 20 seconds to see rapid trending characteristics. Select 5 minutes to see smoother trend changes in values.
20 seconds 5 minutes
Update to Chapter 6, Section 6.4.2, Zero Arterial Pressure
NOTE If the arterial pressure requires too great an offset in order to be zeroed to atmospheric air, the warning “Select Zero point out of tolerance. Check DPT.” is displayed on the screen in red. Verify that the FloTrac sensor has been assembled and flushed correctly, level to the patient’s phlebostatic axis, and try again.
Update to Chapter 10, Section 10.1, Overview In addition to displaying the menus used to set up monitoring operations, the Multipurpose Frame also displays data screens. These screens include: • Graphical Trend Screen (Default) – Displays a historical comparison graph with CO and oximetry plotted by time. • All Data Screen – Displays the most recent values for six parameters. • Tabular Trend Screen – Displays a historical table with values for CO, oximetry and other parameters arranged by time.
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Figure 10-1 Data Screens The current CO Averaging Time is displayed in the lower left of each of the main Multipurpose Frame screens. A 20-second averaging time is represented as 20 . A 5-minute average time is represented as 5 . Update to Appendix A, Table A-3, Technical Specifications The Power Consumption range has been corrected to 40 watts maximum. Table A-3 Technical Specifications Input/Output
Electrical
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Analog Inputs
Selectable full-scale: 0 to 1V 0 to 5V 0 to 10V >100 kΩ input impedance; 1/8 in. stereo jack; Bandwidth = 5 Hz; Resolution: 12 bits ± 1 LSB of full scale
Analog Outputs (1)
Selectable full-scale range: 0 to 1V, 0 to 10V; Bandwidth = 10 Hz; Resolution: 8 bits; Absolute Accuracy = ±2.5%; Linearity = ±1%; 1/8 in. stereo jack
Digital I/O (2)
RS232 programmable serial ports; Maximum data rate = 57.6 kilobaud
Keypad
Six (6) front-panel push buttons: 1 power ON/OFF Five (5) monitoring selections
USB Port
One V1.1-compatible type A connector
Voltage
100 to 240 Volts AC 50/60 Hz
Power Consumption
40 watts, maximum
Fuse
Two 1-amp, 250-volt, Time Lag, Low Breaking Capacitance, 5x20 mm
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Update to Appendix E, Section E-4, Cleaning and Sterilizing the Cable and Connector 1. To clean or disinfect the cable and/or connector use suitable agents such as detergent, isopropyl alcohol, or glutaraldehyde to wipe the surface. 2. Wipe the cable with distilled water to remove all residue. 3. Air dry the connector.
CAUTION If any electrolytic solution (e.g. NaCI, Lactated Ringers) is introduced into the sensor connector of the cable while it is connected to the monitor and the monitor is turned on, the excitation voltage can cause electrolytic corrosion and rapid degradation of the electrical contacts.
CAUTION Do not immerse the connector in detergent, isopropyl alcohol, or glutaraldehyde.
Update to Preface Patents
Patents pending.
Edwards Lifesciences, the stylized E logo, FloTrac, Edwards, SAT-1 and Vigileo are trademarks of Edwards Lifesciences Corporation; Edwards Lifesciences and the stylized E logo are registered in the U.S. Patent and Trademark Office. Flexport and PCMS are trademarks of SpaceLabs Medical, Inc. EC REP Edwards Lifesciences Services GmbH Edisonstr. 6 85716 Unterschleissheim, Germany 05/07 P/N 196077003 A ©Copyright 2007, Edwards Lifesciences LLC All rights reserved.
Edwards Lifesciences LLC One Edwards Way Irvine, CA 92614-5686 USA Made in USA
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